MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SET WITH MICROBORE TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7106-24

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

Operator of device: patient/consumer.No product has been returned to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the tubing had kinks.No patient injury was reported.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H4: device manufacture date: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The customer reported problem was not related to any previous repair.Visual inspection of the device found the sample with marks present in the tube (clamp mark).The customer reported problem was confirmed.The investigation showed that the root cause of the reported problem was due to the clamp being closed or manipulated during the manufacturing process.For corrective action an awareness notification was issued to the production personnel to explain the importance and reinforce the adherence in procedure.The root cause of the reported problem was traced to manufacturing.There were no deviations documented in the device history record, related to the process and components that conforms this device.

• Brand Name: CADD EXTENSION SET WITH MICROBORE TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14946590
• MDR Text Key: 303540618
• Report Number: 3012307300-2022-13049
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7106-24
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 3840936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1